Jan - Feb, 2014
U.S. Medical Research Spending Drops While Asia Makes Gains
The U.S. accounting for over 3⁄4 of world’s research spending is a story of the past, as its share has been dropping over the past 5 years. Researchers found that the U.S. comprised 51% ($131B) of global research spending in 2007, decreased to 45% ($119B), while China and Japan increased $6B and $9B respectively.
Medicaid Raises Emergency Room Visits by 40% compared to the Uninsured
A study found that people on Medicaid are more likely to go to the emergency room (ER) for cases that weren’t emergent. This result is likely to dismiss argu- ments to expand Medicaid, as the common argument was that individuals would no longer have to rely on uncompensated care at the emergency room.
Baxter initiates worldwide voluntary recall of select lots of 5% Dextrose injection, USP and 9% Sodium Chloride injection, USP, IV solutions.
Due to particulate matter found in solutions, Baxter International announced it has initiated a voluntary recall to select lots of injectable. “Injecting a product with the particulate matter may result in blockages of blood vessels; which can result in stroke, heart attack, etc.”
FDA and EMA launch joint Generic Inspections Initiative
The U.S. FDA and the European Medicines Agency have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. Their collaboration with the EMA and EU improves ability to leverage inspection resources and help meet needs of globalization of drugs as well as streamlining the inspection process.
Intercept Pharma, Backed by Former Billionaire, Triples After Drug Test Results
Intercept Pharmaceuticals shares almost tripled (surges over 280%) today after the announcement of early stoppage of its liver disease when primary endpoint of trial was met. Market capitalization of the company jumped to over $5.2 B.
Drug buyers sue Novo Nordisk over ‘wrongful’ delays to diabetes generic
Novo Nordisk has been sued by a group of healthcare purchasing companies in the U.S. for allegedly wrongfully keeping generic copies of its Prandin diabetes drug off the market: also known as pay-for-delay deals.
Eli Lilly & Co.: Lilly falls off second patent cliff
Eli Lilly and Co. on Dec 11 fell off its second patent cliff as Cymbalta, its best-selling drug, saw its U.S. patents expire. Due to the loss of $5 billion in revenue sales of Cymbalta, J.P. Morgan analysts are not anticipating a near-term outperformance, but could lead to a longer-term opportunity for LLY shares for the company’s next-generation product portfolio. *Combined with 2010 patent exp. of cancer drug Gemzar, 2011 patent exp. of antipsychotic Zyprexa, Lilly will suffer from more than $9 billion in annual revenue by the end of 2014.
Merck recall depletes supplies of new cholesterol drug
Merck’s Liptruzet, a cholesterol lowering drug, was voluntarily recalled by the drug maker after only being on the market since last May. The company said the recall “will deplete all available supply in the U.S., and stock-outs are expected.” The reason for the recall was that there was a potential packaging leak that could affect its potency.
Look for an M&A scramble in 2014, with pharma chasing deals at ever-higher prices
Analysis from Ernst & Young reports that Big Pharmas have more money in their pockets for deals and are willing to spend it ASAP to prepare for post-patent-cliff rebuilding. The Big Pharmas didn’t really score big on R&D, so the need for deals remains strong from last year.
Novartis may finally face generic competition for Diovan
Novartis’ blockbuster Diovan will be facing competition for the first time in nearly 18 months since its patent expiration in September 2012. Although there were some delays in seeking an approval from the regulator, Ranbaxy Laboratories, an Indian drug maker, retained 180 days of exclusive marketing rights for the generic version of Diovan.
FDA Advisory Panel Votes In Favor of Approval For Merck’s Vorapaxar
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s thrombin receptor antagonist.
New technique targets specific areas of cancer cells with different drugs
Researhcers at N.Carolina State University and University of N.Carolina at Chapel Hill have developed a technique for in cancer treatment that allows nanoparticles to carry two different cancer-killing drugs and have them be delivered to separate parts of the cancer cell. Early results have been promising and showed significant improvement in cancer tumor reduction compared to conventional treatment techniques.
The FDA granted Soliris with an orphan drug designation
Alexion Pharmaceuticals announced that the FDA granted Soliris (eculizumab) with an orphan drug designation. Soliris is used to prevent delayed graft function (DGF) in patients who undergo kidney transplant surgery. DFG refers to new organ not responding or functioning properly immediately after it has been introduced to the body.
Teva’s New Copaxone Formulation For MS Patients Approved By FDA
The FDA approved the new formulation of Copaxone. The new formulation offers relapsing fomrs of multiple sclerosis (MS) the option to dose less frequently. (now available in 40mg/mL in a three-times-a-week dosage)
NIH, drug companies will partner to expedite new medication
The National Institute of Health announced a partnership with some of major drug companies on a project to reduce the time to create and market medications that treat debilitating diseases. The “Accelerating Medicines Partnership aims to fasten what is now an average 14-year process to create new drugs, and save billions of $. New approach would help pharmaceutical companies pick the right targets in earlier stages of drug development as failure rate for new drug is 95% currently.
Singapore fling: AbbVie says a plant in Asia is just what it needs.
Whilst looking for a new production capacity, Abbvie (the developers of best-selling drug in the world, Humira) has found a location in Singapore for a $320 million manufacturing plant. As they will soon face a significant revenue gap from patent cliff of Humira in 2016, the company is working on a new medicine to fill at least some of the gap. Most anticipated is interferon-free hepatitis C product that can cure up to 90% of the patients with the virus when used in combination with other drugs.
Merck, Samsung Bioepis To Develop & Commercialize Insulin Glargine Candidate
Merck & Co. Inc. announced that it’s partnering with Samsung Bioepis to create a generic version of Sanofi SA’s bestselling insulin drug, Lantus. This agreement threatens Sanofi’s victory against Eli Lilly & Co. in a patent infringement suit over the diabetes medicine. As a result, Eli is likely to hold off their generic version until 2016, but if Merck’s version goes through, it’s going to hurt Sanofi’s market share.
What’s Big Pharma’s latest hot spot? The Middle East
Wall Street Journal reports that the multinational pharma’s latest trend lies in the Persian Gulf. Drugmakers with ambiions are beginning to move into second, third-tier emerging markets as the top-tier BRIC (Brazil, Russia, India, and China) countries are slowing down. The Gulf region has much to offer especially for companies with strong in diabetes, as diabetes is a fast-growing problem across the region.
J&J, Pharmacyclics get CLL approval for Imbruvica
The FDA expanded the approval of Imbruvica, Johnson & Johnson and Pharmacyclics’ new drug for CLL, Chronic Lumphocytic Leukemia (a rare disease), to those who received at least one previous therapy. This allows the former rare disease treatment reach the blockbuster status. Analysts forecast annual sales reaching $1.3 billion in 2018.
Biosimilars Market by Product & Application - Global Forecast to 2018
Increasing prevalence of oncology along with the rise in aging population and the changing lifestyles are what makes oncology the largest and fastest-growing segment of the global biosimilars market. By 2018, global market will be worth $2.0 billion growing at a Compound Annual Growth Rate (CAGR) of 20.1% during 2013-2018.
Forest Laboratories to discontinue NAMENDA® tablets effective Aug. 15,2014
Forest Laboratories is discontinuing Namenda (Memantine HCl) 5mg and 10mn tablets on August 15, 2014. The company announced that the oral solution of Nameda and once-daily Namenda XR capsuels will continue to be available. Both are indicated for treatment of moderate to severe Alzheimer’s disease. The company is discontinuing Namenda tablets not because of lack of benefits of the drug but because the patent for the drug goes off in April of 2015, which means low cost generics will flood the market and replace the original.
“BioMarin and its patients coaches are ready to roll on Vimzim launch
The FDA approved BioMarin Pharmaceutical Inc.’s drug Vimzim to treat a very rare genetic disorder Morquio A Syndrome According to FDA, only about 800 patients in the U.S. have Morquio A syndrome, an enzyme deficiency that causes joint abnormalities and other bone problems. With no other treatments in the market, analysts figure Vimzim could reach at least $500 million in sales.